Concerto Detachable Coil System PV-8-30-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847536045187), received between Sep 25, 2023 and Sep 18, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Positioning Failure; Failure to Advance

  Doctor tried to deploy the Concerto detachable coil system for a splenic bleed but there was too much resistance so he could not do so. No harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817930 ↗
• MalfunctionJun 30, 2026Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WAS BEING USED AS PER THE IFU BUT THE COIL WAS KINKED AND GOT STUCK WITHIN THE MICROCATHETER. A NEW MEDTRONIC DEVICE WAS USED TO FINISH THE PROCEDURE. THE DEVICE ANDANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. IT WAS NOTED THE VESSEL TORTUOSITY WAS UNKNOWN. ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO CAUSES OR CONTRIBUTING FACTORS FOR THE KINK AND RESISTANCE WERE IDENTIFIED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. RESISTANCE LOCATION WITHIN THE CATHETER, WHETHER OR NOT THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY, AND IF THERE WAS ANY KINK/DAMAGE OBSERVED TO THE COIL OR CATHETER AFTER REMOVAL COULD NOT BE RECALLED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THE CATHETER WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25667987 ↗
• MalfunctionApr 10, 2026Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AFTER PREPPING THE DEVICE, THE TECHNICIAN WAS PUSHING THE COIL THROUGH THE CLEAR COIL CATHETER AND INTO THE 2.4FR PROGREAT CATHETER AND WAS MET WITH RESISTANCE. THEY WERE ASKED TO PULL BACK AND THEN CONTINUE TO ADVANCE THE COIL FORWARD. THIS WAS UNSUCCESSFUL AND THE COIL WAS REMOVED. UPON REMOVAL A KINK WAS NOTICED IN THE COIL PUSHER MIDDLE SEGMENT. A SECOND PV-8-30-3D WAS ATTEMPTED WITH THE SAME RESULT. A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING EMBOLIZATION FOR A LIVER RESECTION. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ANCILLARY DEVICES INCLUDE A 6FR TERUMO 25CM SHEATH, SOS CATHETER, AND TERUMO PROGREAT 2.4FR MICROCATHETER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PROCEDURE WAS COMPLETED USING A DIRECT STICK INTO THE LIVER. BOTH COILS HAD KINKS IN THE PUSHWIRE MIDDLE SEGMENT. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THE CAUSE OF THE EVENT WAS NOT DETERMINED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24840992 ↗
• MalfunctionAug 26, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT 2 COILS OF LOT B537338 HAD BEEN USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20063452 ↗
• MalfunctionJul 18, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT 2 COILS OF LOT B537338 HAD BEEN USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19771000 ↗
• MalfunctionSep 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL DEPLOYED IN THE TUOHY. THE CONCERTO AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814281 ↗